The present disclosure relates to heart valve replacement and repair devices such as annuloplasty rings. More particularly, the present disclosure relates to devices and methods for using annuloplasty rings having diagnostic capabilities.
Many anatomic structures in the mammalian body are hollow passages in which walls of tissue define an orifice, which serves as a conduit for blood, other physiologic fluids, nutrient matter, or waste matter passing within the structure. In many physiologic settings, dysfunction may result from a structural orifice which is too large, too small or misshapen. In some cases, dysfunction can be relieved by interventional changes in the orifice size or shape.
Thus in surgery, there is often a desire to reduce or reshape the internal circumference of an orifice or other open anatomic structure to reconfigure the orifice or opening to achieve a desired physiologic effect. Such surgical procedures may require interruption in the normal physiologic flow of blood, other physiologic fluids, or other structural contents through the orifice or structure. The exact amount of the narrowing or reshaping that would result in the desired effect may not be fully appreciated until physiologic flow through the orifice or structure is resumed.
One example of a dysfunction within an anatomic orifice is in the area of cardiac surgery, and specifically valvular repair. Mitral valve disease can be subdivided into intrinsic valve disturbances and pathology extrinsic to the mitral valve ultimately affecting valvular function. Although these subdivisions exist, many of the repair techniques and overall operative approaches are similar in the various pathologies that exist. These dysfunctions may lead to leaflets of the mitral valve failing to coapt correctly, reducing the effectiveness of the mitral valve in acting as a one-way valve. For example, chordae rupture is a common cause of mitral insufficiency, resulting in a focal area of regurgitation. Mitral valve prolapse is a fairly common condition that leads over time to valvular insufficiency. Papillary muscle dysfunction, whether due to infarction or ischemia from coronary artery disease, often leads to mitral insufficiency (commonly referred to as ischemic mitral insufficiency). In addition, in patients with dilated cardiomyopathy the etiology of mitral insufficiency is the lack of coaptation of the valve leaflets from a dilated ventricle, resulting in regurgitation.
Two goals of mitral valve repair may include fixing primary valvular pathology (if present) and supporting or reshaping the valve annulus or reducing the annular dimension using a prosthesis, which may be in the form of a ring or band. One problem encountered in mitral valve repair is the surgeon's inability to fully assess the effectiveness of the repair until the heart has been fully closed, and the patient is weaned off cardiopulmonary bypass. Once this has been achieved, valvular function can be assessed in the operating room using transesophageal echocardiography (“TEE”). If significant residual valvular insufficiency is then documented, the surgeon may need to re-arrest the heart, re-open the heart, and then re-repair or replace the valve. This increases overall operative, anesthesia, and bypass times, and therefore increases the overall operative risks. In addition, even after the surgical procedure has been completed, anatomic structures may change over time or prostheses used to narrow the orifice may become less effective days, months, or years after the procedure. As the effectiveness of the prosthesis declines, physiological problems, such as some amount of regurgitation through the valve, may begin to occur again.